Adjuvant Gemcitabine Regimen Improves PFS in Upper Tract Urothelial Cancer
The 2-year disease-free survival rates were 51% and 70% in the surveillance and chemotherapy arms, respectively.
This article originally appeared in Cancer Therapy Advisor.
Adjuvant gemcitabine-based chemotherapy prolongs progression-free survival (PFS) among patients with upper tract urothelial cancer (UTUC), according to research being presented at the 2018 Gastrointestinal Cancers Symposium in San Francisco, California.
For this phase 3 study of perioperative chemotherapy vs surveillance for UTUC (POUT; ClinicalTrials.gov Identifier: NCT01993979), researchers randomly assigned 345 patients with muscle-invasive or node-positive UTUC who underwent nephro-ureterectomy within the preceding 90 days to gemcitabine plus cisplatin or surveillance with subsequent chemotherapy if needed.
The median follow-up was 17.6 months at time of interim analysis. The 2-year disease-free survival (DFS) rates were 51% (95% CI, 39%-61%) and 70% (95% CI, 58%-79%) in the surveillance and chemotherapy arms, respectively. Patients treated with chemotherapy also had significantly improved PFS vs the surveillance arm (hazard ratio [HR], 0.49; 95% CI, 0.30-0.79; P =.003).
DFS events were reported in 38.2% of patients in the surveillance arm vs 23.2% in the chemotherapy arm (P =.0009). Grade 3 or worse adverse events were reported in 60% and 24% of patients in the chemotherapy and surveillance arms, respectively.
The authors concluded that “whilst follow up for [overall survival] continues, this should be considered a new standard of care in these patients.”
Birtle AJ, Chester JD, Jones RJ, et al. Results of POUT: a phase III randomised trial of perioperative chemotherapy versus surveillance in upper tract urothelial cancer (UTUC). Oral presentation at: 2018 Genitourinary Cancers Symposium; February 8-10, 2018; San Francisco, CA.